SPL Set ID: 05957860-eab3-4172-9877-455540d0c922
1 drug(s) with this SPL Set ID
Fenofibrate capsules USP, is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate USP. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1- methylethyl ester with the following structural formula: The molecular formula is C 20 H 21 O 4 Cl and the molecular weight is 360.83; fenofibrate is very soluble in methylene chloride, slightly soluble in alcohol, practically insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white or almost white, crystalline powder which is stable under ordinary conditions. Inactive Ingredients: Each capsule also contains colloidal silicon dioxide, croscarmellose sodium, D&C red 28, gelatin, magnesium stearate, microcrystalline cellulose, poloxamer, povidone, sodium lauryl sulphate and titanium dioxide. In addition, 67 mg and 134 mg capsule contains FD&C blue 1 and 67 mg and 200 mg capsules contains FD&C red 40 and 200 mg contains iron oxide yellow. The capsules are imprinted with black ink containing black iron oxide, potassium hydroxide and shellac. Meets USP Dissolution Test 7. Chemical Structure